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A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse.

Publication ,  Journal Article
Yung, WK; Albright, RE; Olson, J; Fredericks, R; Fink, K; Prados, MD; Brada, M; Spence, A; Hohl, RJ; Shapiro, W; Glantz, M; Greenberg, H ...
Published in: Br J Cancer
September 2000

A randomized, multicentre, open-label, phase II study compared temozolomide (TMZ), an oral second-generation alkylating agent, and procarbazine (PCB) in 225 patients with glioblastoma multiforme at first relapse. Primary objectives were to determine progression-free survival (PFS) at 6 months and safety for TMZ and PCB in adult patients who failed conventional treatment. Secondary objectives were to assess overall survival and health-related quality of life (HRQL). TMZ was given orally at 200 mg/m(2)/day or 150 mg/m(2)/day (prior chemotherapy) for 5 days, repeated every 28 days. PCB was given orally at 150 mg/m(2)/day or 125 mg/m(2)/day (prior chemotherapy) for 28 days, repeated every 56 days. HRQL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 [+3]) and the Brain Cancer Module 20 (BCM20). The 6-month PFS rate for patients who received TMZ was 21%, which met the protocol objective. The 6-month PFS rate for those who received PCB was 8% (P = 0.008, for the comparison). Overall PFS significantly improved with TMZ, with a median PFS of 12.4 weeks in the TMZ group and 8.32 weeks in the PCB group (P = 0.0063). The 6-month overall survival rate for TMZ patients was 60% vs. 44% for PCB patients (P = 0.019). Freedom from disease progression was associated with maintenance of HRQL, regardless of treatment received. TMZ had an acceptable safety profile; most adverse events were mild or moderate in severity.

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Published In

Br J Cancer

DOI

ISSN

0007-0920

Publication Date

September 2000

Volume

83

Issue

5

Start / End Page

588 / 593

Location

England

Related Subject Headings

  • Time Factors
  • Temozolomide
  • Recurrence
  • Quality of Life
  • Prognosis
  • Procarbazine
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
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Yung, W. K., Albright, R. E., Olson, J., Fredericks, R., Fink, K., Prados, M. D., … Levin, V. A. (2000). A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse. Br J Cancer, 83(5), 588–593. https://doi.org/10.1054/bjoc.2000.1316
Yung, W. K., R. E. Albright, J. Olson, R. Fredericks, K. Fink, M. D. Prados, M. Brada, et al. “A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse.Br J Cancer 83, no. 5 (September 2000): 588–93. https://doi.org/10.1054/bjoc.2000.1316.
Yung WK, Albright RE, Olson J, Fredericks R, Fink K, Prados MD, et al. A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse. Br J Cancer. 2000 Sep;83(5):588–93.
Yung, W. K., et al. “A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse.Br J Cancer, vol. 83, no. 5, Sept. 2000, pp. 588–93. Pubmed, doi:10.1054/bjoc.2000.1316.
Yung WK, Albright RE, Olson J, Fredericks R, Fink K, Prados MD, Brada M, Spence A, Hohl RJ, Shapiro W, Glantz M, Greenberg H, Selker RG, Vick NA, Rampling R, Friedman H, Phillips P, Bruner J, Yue N, Osoba D, Zaknoen S, Levin VA. A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse. Br J Cancer. 2000 Sep;83(5):588–593.

Published In

Br J Cancer

DOI

ISSN

0007-0920

Publication Date

September 2000

Volume

83

Issue

5

Start / End Page

588 / 593

Location

England

Related Subject Headings

  • Time Factors
  • Temozolomide
  • Recurrence
  • Quality of Life
  • Prognosis
  • Procarbazine
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans